The purpose of this study is to evaluate changes in vascular parameters in subjects receiving Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one time) versus subjects receiving Compounded Testosterone pellets 200mg (one time) to participant with clinical hypogonadism.
Hypogonadism, or low testosterone (Low T), is the deficiency in producing testosterone by the testes. Testosterone pellets is a long-acting formulation of Testosterone Replacement Therapy (TRT) that is delivered subcutaneously to men diagnosed with low T. Advantages to subcutaneous testosterone pellets include ease of delivery and decreased risk of the medication being transfer upon skin contact to woman or children. Long acting testosterone replacement Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month post-implantation and sustained therapeutic levels (\>300) for 4-6 months. Participants will be randomly assigned to 1 of 3 study groups. In one of the groups the treatment will include implantation of Testopel ® 750mg (10 pellets with 75mg pellet) one time, in the second group, treatment will include compounded subcutaneous testosterone 800mg (8 pellets with 100mg pellet) one time and in the third group, treatment will include compounded subcutaneous testosterone 800mg (4 pellets with 200mg pellet) one time. The treatment takes approximately 30 minutes and will include: Clean and numb the insertion site with lidocaine at 1%, followed by small incision in the skin, implantation of pellets into subdermal fat layer and sealing the incision with Steri-strip. This is the current standard of care of Testopel insertion and same procedure will be followed with both compounded and commercial pellets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
75 mg Testosterone pellets administered subcutaneously.
100 mg Testosterone pellets administered subcutaneously.
200 mg Testosterone pellets administered subcutaneously.
University of Miami, Department of Urology
Miami, Florida, United States
Change in Testosterone (T) Levels
Changes in serum Testosterone levels are assessed in ng/dL
Time frame: Baseline, 2 months, 4 months, and 6 months
Change in Hematocrit (Hct) Levels.
Changes in serum Hct levels are assessed in %.
Time frame: Baseline, 2 months, 4 months, and 6 months
Change in PSA Levels
Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months
Change in Estradiol Levels
Change in serum estradiol levels are assessed in pg/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.